Description
Responsibilities -- Manages studies with single or dual modalities from start-up to close-out.
- Manages all communications with the sponsor regarding timelines and study specific deliverables.
- Facilitates regular meetings with the sponsor and study team
- Leads the study team, which includes representatives from all functions supporting the study.
- Develops and maintains project plans that encompass all contracted deliverables.
- Tracks study progress and escalates issues that require resolution.
- Provides regular internal status updates to the study team and senior management.
- Coordinates the development of study specific procedures.
- Reviews work performed and validates invoices.
- Prepares financial and activity forecasts for capacity planning.
- Identifies need for change orders and works with the Account Executive to obtain sponsor approvals.
- Creates and maintains project plans and schedules.
- Creates meeting agendas and minutes to include action items.
- Tracks progress of audit action items to completion.
- Prepares internal and external project reports.
- Sets up and maintains the Master Study Binder for each assigned project.
- Maintains proper documentation for all assigned projects.
Education / Qualifications:
- B.S./M.S. in science, medical/health-related field, or business administration
- Familiarity with late stage drug or medical device development;
- Familiarity with project management concepts.
- Desired: service provider experience, global clinical trials experience, and/or knowledge and experience with multiple imaging modalities.
- Demonstrated ability to effectively communicate to external sponsors and internal cross-functional project teams.
- Strong time management and organizational skills.
- Strong written and oral communication skills in English.
- Ability to manage and mobilize a study team that does not report directly to you.
- Ability to make quick decisions, solve problems, and adapt to changing environments and requirements.
- Proficiency with MS Office applications, and experience with MS Project, or other project management software.
To find out more about Real please visit www.realstaffing.com